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目的探讨国产西罗莫司洗脱支架与裸支架治疗急性心肌梗死(AMI)临床疗效的差异。方法 173例连续行直接 PCI 的 AMI 患者随机分为西罗莫司洗脱支架组(87例)和裸支架组(86例),分析住院期间和支架置入后6个月的支架内血栓、主要心血管事件(包括再次心肌梗死、缺血性靶血管重建和死亡)发生率及6个月再狭窄率。结果两组患者在术后血管通畅、肌酸激酶峰值、心功能和住院期间心脏事件方面差异均无统计学意义(P>0.05)。两组各有2例支架内血栓(2.4%比2.3%,P>0.05)。6个月时,国产西罗莫司洗脱支架组的支架内再狭窄率(4.5%比40.0%,P<0.01)、节段内再狭窄率(6.8%比44.9%,P<0.01)和主要不良心脏事件发生率(8.0%比24.4%,P<0.01)显著低于裸支架组。国产西罗莫司洗脱支架组主要心脏事件的减少主要是因为缺血性靶血管重建减少所致(3.4%比11.6%,P<0.05)。结论与裸支架相比,国产西罗莫司洗脱支架治疗AMI 患者并未增加6个月内支架内血栓的发生,而显著降低6个月的再狭窄率和主要心脏事件发生率。
Objective To investigate the clinical efficacy of domestic sirolimus-eluting stents versus bare stents in the treatment of acute myocardial infarction (AMI). Methods A total of 173 consecutive AMI patients undergoing direct PCI were randomly divided into two groups: the sirolimus-eluting stent group (87 cases) and the bare stent group (86 cases). The stent thrombosis during hospitalization and 6 months after stent implantation was analyzed. Incidence of major cardiovascular events (including recurrent myocardial infarction, ischemic target revascularization, and death) and rates of 6-month restenosis. Results The postoperative vascular patency, peak creatine kinase, cardiac function and cardiac events during hospitalization were not significantly different between the two groups (P> 0.05). There were 2 cases of stent thrombosis in each group (2.4% vs 2.3%, P> 0.05). At 6 months, the rate of in-stent restenosis (4.5% vs. 40.0%, P <0.01), intra-articular restenosis (6.8% vs. 44.9%, P <0.01) The incidence of major adverse cardiac events (8.0% vs 24.4%, P <0.01) was significantly lower than that of the bare stent group. The decrease in major cardiac events in the domestic sirolimus-eluting stent group was mainly due to a decrease in ischemic target vessel remodeling (3.4% vs. 11.6%, P <0.05). Conclusion Compared with bare stent, domestic sirolimus-eluting stents in AMI patients did not increase stent thrombosis within 6 months, but significantly reduced the 6-month restenosis rate and the incidence of major cardiac events.